Intervertebral Disc Disease, Spinal Fractures, Spinal Neoplasms, Spinal Stenosis, Spondylolisthesis
Conditions
Brief summary
Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017. The inclusion period will be 12 months and the follow-up 24 months
Detailed description
The primary endpoint is to evaluate the safety of the PASS OCT® system. The secondary endpoints are to analyze the efficacy of the system with several point of view: * The quality of fusion and the time of fusion through X rays * the pain with VAS * the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy * the daily of the patient: return to work, sport * the surgeon satisfaction.
Interventions
DEVICEPASS OCT® Spinal System
Posterior osteosynthesis of the cervical and upper thoracic spine
Sponsors
Medicrea International
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with * degenerative disc disease or, * spondylolisthesis, or * spinal stenosis, or * trauma, or * atlanto-axial fractures with instability or * cervical tumors. * Patient operated with PASS OCT® * Patient \> 18 years * Patient affiliated to health care insurance (social security in France) * Patient able to complete a self-administered questionnaire * Patient able to understand the protocol and the planning visit * Patient able to sign an informed consent form
Exclusion criteria
* Patient unable or unwilling to sign an informed consent form * Patient unable to complete a self-administered questionnaire * Pregnant patient or intending to get pregnant within the next 3 years * Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 12 months postoperatively | To quantify and describe adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fusion | 1-6 months, 12 months, 24 months postoperatively | Radiological assessment of bony fusion |
| Disability | 1-6 months, 12 months, 24 months postoperatively | To assess disability using NDI score |
| Quality of life | 1-6 months, 12 months, 24 months postoperatively | To assess quality of life through mJOA scoring system |
| Pain | 1-6 months, 12 months, 24 months postoperatively | To assess pain using visual analogue scale |
Countries
France
Outcome results
None listed